Effect of a Multivitamin Supplement With Probiotic (Seidivid Ferty4®) on Oocyte Retrieval and Quality (OvoVid)

OvoVid Study: Effect of a Multivitamin Supplement With Probiotic (Seidivid Ferty4®) on Oocyte Retrieval and Quality in Oocyte Donors. Double-blind Randomized Placebo-controlled Clinical Trial

This study evaluates the effect of pretreatment with a multivitamin supplement with probiotics (Seidivid Ferty4®) on oocyte retrieval in normo-responder patients undergoing controlled ovarian hyperstimulation (COH) for oocyte donation, considering both the total number of oocytes retrieved and the number of mature oocytes retrieved, that is, in metaphase II (MII).

Study Overview

• Status: Recruiting
• Conditions: Reproductive Techniques, Assisted
• Intervention / Treatment: Dietary supplement: Seidivid Ferty4; Other: Placebo

Detailed Description

Patients will be recruited on the day they are going to start the egg donation program. The patient will start taking the study treatment (multivitamin supplement with probiotics or placebo) immediately after inclusion and will call the site to initiate the oocyte donation protocol approximately 30 days after enrollment. Throughout the COH period of the protocol the patient will continue taking the study supplement (or placebo), without interruption until the day of the GnRH-agonist trigger. The administration of the agonist will be as a single dose, 36 hours before follicular puncture for the retrieval of mature eggs. Then, the retrieved oocytes will be denuded and examined by light microscopy to assess their quality. The evaluation will carried out by two different embryologists, blinded to the study protocol.

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana Gavilan; Phone Number: +34938445730; Email: agavilan@lab-seid.com
• Study Contact Backup: Name: Montse Vidal, Ph; Phone Number: +34663825890; Email: montsevidal@crossdata.es

Study Locations

• Spain
  • Valencia, Spain, 46009
    • Recruiting
    • NextFertility
    • Contact: Silvia Bonta, Ph; Email: silvia.bonta@nextfertility.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women undergoing COH for egg donation cycles
• Signing of Informed Consent
• Age 18-34 years
• Body mass index between 18-29.9 kg/m2
• Meet the criteria for inclusion in the oocyte donation program of the Next Fertility center
• Ultrasound antral follicle count before COH of ≥15 follicles

Exclusion Criteria:

• Patients excluded from the oocyte donation program
• Untreated sexually transmitted disease, HIV, HCV, HBV positive serology
• Blood disorders, neurodegenerative/psychiatric diseases, fragile X syndrome, oncological diseases, endometriosis.
• Polycystic ovary syndrome
• Oligomenorrhea (<1 menstrual cycle in 3 months)
• Diabetic patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Seidivid Ferty4; Patients included in this group will be administered dietary supplement Seidivid Ferty4 (2 capsules per day, as a single dose) for at least 30 days prior to controlled ovarian hyperstimulation and until the day of the agonist trigger (GnRH a).	Dietary supplement: Seidivid Ferty4; The patient will start taking the study treatment (multivitamin supplement with probiotics) immediately after inclusion. Throughout the COH period of the protocol (usual mean duration: 11 days) the patient will continue taking the diatary supplement, without interruption until the day of the GnRH-agonist trigger.
Placebo Comparator: Placebo; Patients included in this group will be administered placebo (2 capsules per day, as a single dose) for at least 30 days prior to controlled ovarian hyperstimulation and until the day of the agonist trigger (GnRH-a).	Other: Placebo; The patient will start taking the study treatment (placebo) immediately after inclusion. Throughout the COH period of the protocol (usual mean duration: 11 days) the patient will continue taking the treatment (placebo), without interruption until the day of the GnRH-agonist trigger.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of oocytes retrieved	Total number of oocytes retrieved in the follicular puncture	Through study completion, an average of 42 days
Number of mature (MII) oocytes retrieved	Total number of mature oocytes (metaphase II, or MII) retrieved in the follicular puncture	Through study completion, an average of 42 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of normal or good quality oocytes	Percentage of mature oocytes MII without dimorphisms respect to the total mature oocytes MII retrieved	Through study completion, an average of 42 days
Rate of oocytes with dimorphisms	Percentage of mature oocytes MII with dimorphisms respect to the total mature oocytes MII retrieved	Through study completion, an average of 42 days
Rate of oocytes with intra-cytoplasmic dimorphisms	Percentage of mature oocytes MII with intra-cytoplasmic dimorphisms respect to the total mature oocytes MII retrieved	Through study completion, an average of 42 days
Rate of oocytes with extra-cytoplasmic dimorphisms	Percentage of mature oocytes MII with extra-cytoplasmic dimorphisms respect to the total mature oocytes MII retrieved	Through study completion, an average of 42 days
Number of antral follicles at study inclusion	Ultrasound antral follicle count at study inclusion	Baseline
Number of antral follicles at the time of COH start	Ultrasound antral follicle count at the time of controlled ovarian hyperstimulation (COH) start	Through COH start, an average of 30 days
Number of follicles at the time of trigger administration	Ultrasound follicle count at the time of trigger administration	Through trigger administration, an average of 40 days
Baseline fasting glucose	Fasting blood glucose at the time of study inclusion	Baseline
Fasting glucose at the time of COH start	Fasting blood glucose at the time of controlled ovarian hyperstimulation (COH) start	Through COH start, an average of 30 days
Baseline AST	Serum aspartate aminotransferase (AST) levels at the time of study inclusion	Baseline
AST at the time of COH start	Serum aspartate aminotransferase (AST) levels at the time of controlled ovarian hyperstimulation (COH) start	Through COH start, an average of 30 days
Baseline ALT	Serum alanine aminotransferase (ALT) levels at the time of study inclusion	Baseline
ALT at the time of COH start	Serum alanine aminotransferase (ALT) levels at the time of controlled ovarian hyperstimulation (COH) start	Through COH start, an average of 30 days
Baseline Cholesterol	Total cholesterol at the time of study inclusion	Baseline
Cholesterol at the time of COH start	Total cholesterol at the time of controlled ovarian hyperstimulation (COH) start	Through COH start, an average of 30 days
LH at the time of COH start	Plasma levels of luteinizing hormone (LH) at the time of controlled ovarian hyperstimulation (COH) start	Through COH start, an average of 30 days

Collaborators and Investigators

• Sponsor: SEID S.A.
• Investigators: Study Director: Luis Quintero, Ph, NextFertility Valencia

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): December 28, 2024

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: dietary supplement; oocyte maduration; oocyte donation
• Other Study ID Numbers: OVOVID-FERTY4-2022-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make IPD available because the voluntary participating oocyte donors are healthy women and are not amenable to further follow-up.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No